Status:
COMPLETED
Study Comparing Efficacy and Safety of Amaryl M and Metformin Uptitraion to Type 2 DM
Lead Sponsor:
Handok Inc.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
Brief Summary
The aim of this study is to compare the efficacy and safety of early combination therapy with Amaryl M with that of uptitration of metformin monotherapy in patients with type 2 DM inadequately control...
Detailed Description
Treatment algorithms for type 2 DM generally employ monotherapy as a first-line pharmacologic treatment option. Disease progression renders monotherapy less effective in controlling blood glucose over...
Eligibility Criteria
Inclusion
- Ages 30 to 75 at the time of screening visit
- Subjects with type 2 DM diagnosed for at least 3 months before screening
- Subjects with type 2 DM treated with monotherapy of 500mg ≤ metformin ≤ 1000mg for at lest 4 weeks prior to screening
- HbA1c ≥ 7.0% but ≤ 10.0% at the time of screening visit
- 21 kg/m2 ≤ BMI ≤ 40 kg/m2
- A negative pregnancy test for all females of childbearing potential
- Provision of signed and dated informed consent prior to any study procedures
- Ability and willingness to perform SMBG and record the data on the subject's diary
Exclusion
- A history of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening
- Current therapy with anti-hyperglycemic agents (except metformin) use in the 4 weeks (8 weeks in case of thiazolidinedione) before screening
- Concomitant treatment prohibited during the study period
- Any oral hypoglycemic agent other than glimepiride, metformin HCl, and fixed-dose combination of glimepiride and metformin HCl
- Any insulin therapy over 7 days consecutively or intermittently in order to treat acute metabolic decompensation or systemic infection during the study
- Intermittent use of systemic corticosteroids or large dose of inhaled steroids
- Subjects with clinically significant renal (serum creatinine level \> 1.5 mg/dL in male and \> 1.4 mg/dL in female) or hepatic disease (ALT and AST \> 2x ULN)
- Clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study in the opinion of the investigator and/or sponsor;
- Pregnant or lactating females
- History of drug or alcohol abuse
- Subjects who have a history of noncompliance with regards to follow-up medical care
- Subjects with known hypersensitivity to glimepiride, metformin HCL
- Night-shift workers
- Treatment with any investigational product in the last 3 months before study entry
- Others; subjects who have participated in this study
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT00612144
Start Date
December 1 2007
End Date
May 1 2009
Last Update
March 28 2013
Active Locations (1)
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1
Handok Pharmaceuticals, Co., LTD
Seoul, South Korea